Events

Rappel de Novel VBR Spinal System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Alphatec Spine, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    48177
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0508-2009
  • Date de mise en oeuvre de l'événement
    2007-08-16
  • Date de publication de l'événement
    2008-12-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-01-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74679
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Spinal Vertebral Body Replacement Device - Product Code MQP
  • Cause
    Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. they were incorrectly laser marked with the wrong part numbers and sizes. two lots were mixed from the following lot numbers: part number 64733-120 lot number 611884, and part number 64753-126 and lot number 611881.
  • Action
    The recall was initiated on August 16, 2007 with Alphatec Spine contacting each of the four direct distributors by telephone. This was followed with a Product Recall Notice, dated August 27, 2007, that was mailed to all affected customers. The distributors were informed that the firm was conducting a voluntary recall because two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. The firm asked the customers to return the product, and were informed that replacement product will be sent back.

Device

Novel VBR Spinal System
  • Modèle / numéro de série
    Lot Number: 611881
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution --- including states of AZ, FL, NY & TX.
  • Description du dispositif
    Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers : 64753-126. || Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). Intended for use with supplemental spinal fixation systems.
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • Adresse du fabricant
    Alphatec Spine, Inc., 2051 Palomar Airport Rd Ste 100, Carlsbad CA 92011-1462
  • Société-mère du fabricant (2017)
    Alphatec Spine Inc
  • Source
    USFDA